Label: ALL DAY ALLERGY RELIEF 24 HOUR- cetirizine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 55910-220-14 - Packager: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 15, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
Adults and children 6 years and over Take one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms Adults 65 years and over Ask a doctor Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor - Other information
- Inactive ingredients
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Principal Display Panel
All Day Allergy Relief 24 HOUR
Cetirizine Hydrochloride Antihistamine, 10 mg
- Sneezing
- Runny nose
- Watery eyes
- Itchy eyes, nose & throat
INDOOR & OUTDOOR ALLERGY
Tablets
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Visit us at: Rexall.com or call 1-866-4-REXALL
PACKAGED FOR DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA
- Package Labeling
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INGREDIENTS AND APPEARANCE
ALL DAY ALLERGY RELIEF 24 HOUR
cetirizine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-220 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL (UNII: 532B59J990) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code W989 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-220-14 1 in 1 CARTON 1 14 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078427 10/19/2012 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990) Registrant - P and L Development of New York Corporation (800014821)